BISACODYL- bisacodyl enteric coated tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BISACODYL (UNII: 10X0709Y6I) (BISACODYL - UNII:10X0709Y6I)

Available from:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (International Name):

BISACODYL

Composition:

BISACODYL 5 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

 Stimulant laxative  -relieves occasional constipation and irregularity  -this product generally produces bowel movement in 6 to 12 hours

Authorization status:

OTC monograph not final

Summary of Product characteristics

BISACODYL- BISACODYL ENTERIC COATED TABLET, COATED
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
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BISACODYL ENTERIC COATED TABLET
ACTIVE INGREDIENT(S)
Bisacodyl 5mg
PURPOS E
Stimulant laxative
US E(S )
-relieves occasional constipation and irregularity
-this product generally produces bowel movement in 6 to 12 hours
WARNINGS
DO NOT USE
Do not use if you cannot swallow without chewing
ASK A DOCTOR BEFORE USE IF
-you have a sudden change in bowel habits that lasts more than 2 weeks
-stomach pain, nausea or vomiting
WHEN USING THIS PRODUCT
-do not use within 1 hour after taking an antacid or milk
-do not chew or crush tablet(s)
-you may have stomach discomfort, faintness or cramps
STOP USE AND ASK A DOCTOR IF
-you have rectal bleeding or fail to have a bowel movement after use
of a laxative. These could be
signs of a serious condition.
-you need to use a laxative for more than 1 week
IF PREGNANT OR BREASTFEEDING
ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN
In case of overdose, get medical help or contact a Poison Control
Center right away.
DIRECTIONS
-take with a glass of water
adults and children 12 years and over- take 1 to 3 tablets in a single
daily dose
children 6 to under 12 years of age - take 1 tablet in a single daily
dose
children under 6 years of age - ask a doctor
OTHER INFORMATION
-store at 25ºC (77º F) excursions permitted between 15º-30º C
(59º-86º F)
-use by expiration date on package
-protect from excessive humidity
INACTIVE INGREDIENTS
acacia, anhydrous calcium sulfate, anhydrous lactose, carnauba wax,
colloidal silicon dioxide, corn
starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake,
gelatin, iron oxide, iron oxide
black, iron oxide yellow (iron oxide ochre), magnesium stearate,
microcrystalline cellulose,
polyethylene glycol (PEG) 400, polyv